Eur J Anaesthesiol 2015; 32:8384
INVITED COMMENTARY
Standardisation of perioperative outcome measures
Michael P.W. Grocott
European Journal of Anaesthesiology 2015, 32:8384
This Invited Commentary accompanies the follow-
ing article:
Jammer Ib, Wickboldt N, Sander M, et al. Standards
for definitions and use of outcome measures for
clinical effectiveness research in perioperative medi-
cine: European Perioperative Clinical Outcome
(EPCO) definitions. A statement from the ESA-
ESICM joint taskforce on perioperative outcome
measures. Eur J Anaesthesiol 2015; 32:88105.
In God we trust; all others must bring data.
W. Edward Deming (19001993)
Le bon Dieu est dans le detail (the good God is in the
detail)
Gustave Flaubert (18211880)
Which measures best define outcome following major
surgery? The answer to this apparently dull and esoteric
question has major implications for any clinician passio-
nate about improving perioperative patient care. Clinical
decisions should be based on the best available infor-
mation. The highest standard of evidence in clinical
medicine is a systematic review of high-quality random-
ised controlled trials (RCTs) with limited heterogeneity.
Although some areas of clinical practice are blessed with a
large number of homogeneous high-quality RCTs, other
areas are less well served. Perioperative care is one such
area; heterogeneity is common and is a substantial threat
to the effective application of high-quality clinical evi-
dence for patient benefit. Heterogeneity undermines
evidenced-based medicine by limiting our capacity to
compare, contrast and combine results from different
studies. Specifically, heterogeneity may preclude the
From the Anaesthesia and Critical Care Research Unit, University Hospital Southampton NHS Foundation Trust, the Integrative Physiology and Critical Illness Group,
Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, University Road, and the Critical Care Research Area, Southampton NIHR Respiratory
Biomedical Research Unit, Southampton, UK
Correspondence to Michael P.W. Grocott, University Hospital Southampton, Mailpoint 24,CE93, E Level, Centre Block, Tremona Road, Southampton SO16 6YD, UK
Tel: +44 238 120 5308; e-mail: mike.grocott@soton.ac.uk
0265-0215 2015 Copyright European Society of Anaesthesiology
Copyright European Society of Anaesthesiology. Unauthorized reproduction of this article is prohibited.
pooling of data from different papers in a meta-analysis,
thereby robbing clinicians of the opportunity to benefit
from the combined power of studies addressing the same
clinical question. Alternatively, where such an analysis is
undertaken, study heterogeneity reduces confidence in
the direction and magnitude of a calculated treatment
effect.1
The analogy of comparing apples and pears is commonly
used to highlight the limitations inherent in the analysis
of heterogeneous data. Clinical heterogeneity (as distinct
from methodological or statistical heterogeneity) is often
thought of in terms of settings, participants and inter-
ventions, but variation in outcome reporting is an import-
ant example. Differences between studies in the way
outcomes are defined and when they are reported may
lead to differences in the observed intervention effects.1
Although reporting of primary outcome variables may be
similar in most or all studies in a systematic review,
analysis of secondary outcomes is frequently limited by
marked heterogeneity of criteria and timing. A recent
Cochrane systematic review of perioperative haemody-
namic management2 included 31 eligible studies and
reported that No two studies used the same list of
morbidities after surgery. In most cases, no specific
criteria were listed for morbidities. No two studies used
the same criteria. The authors concluded that Diverse
criteria and descriptions for morbidities, along with infre-
quent use of validated metrics, limited the precision of
treatment effect estimates and the confidence that can be
attached to them. Furthermore, pooling of different types
of morbidity was inconsistent, limiting assessment of the
overall morbidity load.
The publication of Standards for definitions and use of
outcome measures for clinical effectiveness research in
perioperative medicine: European Perioperative Clinical
Outcome (EPCO) definitions in this issue of the
European Journal of Anaesthesiology is a welcome step
towards standardisation of outcome reporting in the peri-
operative literature.3 A joint taskforce of the European
DOI:10.1097/EJA.0000000000000156
 84 Grocott
Society of Intensive Care Medicine (ESICM) and the
European Society of Anaesthesiology (ESA) led by Pro-
fessor Rupert Pearse (UK) reports the results of a struc-
tured process leading to the identification of a list of
suggested outcomes for perioperative studies along with a
proposed severity grading system. The standards include
specific definitions of adverse events, composite out-
comes describing short-term postoperative harm and
quality of recovery, and health-related quality of life
measures. The focus on duration of follow-up for out-
comes reporting is welcome and reflects increasing recog-
nition of the long-term implications of events occurring
around the time of surgery.4,5 The group recommends
that mortality data be reported at a minimum of 90 days
following surgery and ideally at 1 year. Definitions for
individual adverse events derive from a variety of sources.
In some cases, definitions are based on industry standard
criteria used across many specialties, for example the
USA Center for Disease Control (CDC) definitions for
infection. For other outcomes, including postoperative
haemorrhage and stroke, the group adopts definitions
used by the well established American College of
Surgeons - National Surgical Quality Improvement Pro-
gramme (ACS-NSQIP) in the United States (http://
site.acsnsqip.org/wp-content/uploads/2012/03/ACS-NSQ
IP-Participant-User-Data-File-User-Guide_06.pdf [Acc-
essed 22 July 2014]). For a handful of outcomes, arbitrary
definitions with no referenced source are adopted (e.g.
deep vein thrombosis, cardiogenic pulmonary oedema).
This reflects current inconsistency, and in some cases
controversy, around the criteria defining these phenom-
ena. There are some inevitable inconsistencies. The
definition of acute myocardial infarction included in
the composite measure of Major Adverse Cardiac Events
(MACE) is not the same as the criteria suggested when
this diagnosis is listed alone. The inclusion of the recently
suggested definition for Myocardial Injury after Non-
Cardiac Surgery (MINS) is interesting and may contrib-
ute to the wider adoption of this construct.6 Notwith-
standing these minor issues, this publication is a
landmark for Health Services Research in anaesthesia
and an important step in the development of the specialty
of perioperative medicine.7
Looking forward, this document will be a valuable input
into the Core Outcome Measures in Effectiveness Trials
(COMET) initiative for perioperative and anaesthetic
care (http://www.niaa-hsrc.org.uk/COMPAC). The aim
of the COMET process is to define a core outcome set
for all studies to enable reliable comparison and combi-
nation of trial data.8 Importantly, this allows investigators
to increase the value of their studies whilst placing no
restriction on the breadth of outcomes reported by
particular studies for specific purposes. The COMET
process involves the establishment of a stakeholder group
incorporating patients, carers and health professionals,
Eur J Anaesthesiol 2015; 32:8384
Copyright European Society of Anaesthesiology. Unauthorized reproduction of this article is prohibited.
including doctors. A protocol is developed and agreed in a
manner analogous to that used for high-quality systematic
reviews. The three key steps are a comprehensive and
systematic approach to identifying a long-list of relevant
outcomes, a Delphi process involving all stakeholders to
select a short-list of candidate outcomes and a final
consensus process to agree the core outcome set.
The ESICM and ESA should be congratulated for having
the foresight to support the Joint Taskforce on Clinical
Outcome Measures. The standards the Taskforce have
produced highlight the importance of consistency of out-
comes reporting between studies and provide a useful and
up-to-date summary of many of the commonly used
measures. This is an important step on the journey towards
standardisation of reporting of perioperative outcomes.
Such progress improves our capacity to compare, contrast
and combine data from clinical effectiveness studies. The
benefit for clinicians and patients will be better infor-
mation on which to base important clinical decisions
and improved care for patients undergoing surgery.
Acknowledgements relating to this article
Assistance with the Commentary: none.
Financial support and sponsorship: The author is paid by the Royal
College of Anaesthetists (UK) for his role as director of the UK
National Institute of Academic Anaesthesia (NIAA) Health Ser-
vices Research Centre (HSRC).
Conflicts of interest: The author is director of the UK National
Institute of Academic Anaesthesia (NIAA) Health Services
Research Centre (HSRC) and chair of COMPAC (Core Outcome
Measures in Perioperative and Anaesthetic Care). He also serves on
the board of the UK Faculty of Intensive Care Medicine.
Comment from the Editor: this Invited Commentary was checked
and accepted by the editors but was not sent for external peer review.
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